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VITROS HBeAg

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: Ortho-Clinical Diagnostics, Inc.
Trade Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 5/11/2011
Days to Decision: 511 days
Decision Code: APPR
FDA Decision: Approval